Lumbar Herniated DiscO3HDCIRUGIANCT03282695

Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study

An observational study of Lumbar Herniated Disc, run by Bernardino Clavo, MD, PhD at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of this study is to estimate the cost-effectiveness of ozone therapy in patients on the waiting list for surgery due to disc herniation. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lumbar Herniated Disc
How many people: 70 participants
Where: 1 siteSpain
Study dates: 9 Mar 2018to 31 Mar 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adults with symptomatic lumbar herniated disc in whom conservative medical management has failed and: 1) in whom discectomy or microdiscectomy is indicated, 2) have been included in surgery waiting list by the Neurosurgery Department, 3) who meet criteria for potential benefit with ozone therapy and 4) who accept participating in the study by answering/filling in the specific study questionnaires (wether they accept or not the ozone therapy).

Who may be able to join

Diagnosed with a herniated and not calcified lumbar disc that presents as: not migrated protrusion and/or extrusion.
Evaluated and diagnosed by the Neurosurgery Department, having been chosen as an appropriate candidate for surgery consisting in discectomy or microdiscectomy, after meeting the following two criteria: 1) Sciatic pain, with a visual analogue scale (VAS) intensity ≥ 5, despite 6 weeks of conservative management, wether it exists lumbar pain or not and 2) Radiating pain that matches the MRI image showing one or more herniated discs (not to be considered those patients with two herniated discs and symptoms attributable to only one of the herniated discs).
Included in the surgery waiting list for a discectomy or microdiscectomy.
Patients who have signed and dated the study 's specific informed consent.

Who cannot join

Patients who do not meet all the inclusion criteria.
Calcified and/or migrated herniated disc, and/or with a severe neurological deficits (cauda equine syndrome).
Herniated disc with surgical indication of laminectomy and/or arthrodesis (massive extrusion, sign of instability or other conditions under the neurosurgeon judgment).
Relevant clinical paresis that does not improve despite 6 weeks of full conservative management (patients with severe pain and mild paresis that only shows up in the physical exam are not to be excluded, but those who present with paresis as the main symptom -"clinically relevant"- must be).
Simultaneous symptomatic cervical or dorsal herniated discs.
Previous lumbar spine surgery.

Show all 10Show fewer

Concomitant spine conditions that may be causing symptoms or have indication for surgery (such as fractures or tumors).
Known allergy to ozone.
Those who are uncapable to fill in the scales used to measure variables in the study, like the visual analogue scale (VAS), Roland-Morris and SF-12 questionnaires.
Those who are unable or do not wish to fulfill the study 's protocol (answer questions to collect the data).

Trial locations and contacts

1 site in 1 country.

Spain1 site

Dr. Negrin University Hospital
Las Palmas de Gran Canaria, Las Palmas, 35019

Other trials in Spain

About this study

The main objective of this study is to estimate the cost-effectiveness of ozone therapy in patients on the waiting list for surgery due to disc herniation.

Read the detailed description

A cohort study (patients on the waiting list for surgery due to herniated disc) will be carried out, to which the treatment with ozone will be offered, without giving up the planned surgical intervention.

The main objective of this prospective, post-authorization follow-up study is to estimate the cost-effectiveness of ozone therapy (compared to standard care) in patients with disc herniation waiting for surgery (by microdiscectomy). Besides utilities of patients with disc herniation on a waiting list for surgery will be estimated, social/economic burden of disc herniation will be quantified and a decision aid will be developed and applied.

The main outcome measures are "Direct hospital cost", "Percentage of executed surgeries" and "Change in sciatic pain". In addition, data on health-related quality of life and resource utilization will be collected which will permit to estimate the incremental cost-effectiveness ratio (ICER), comparing incremental costs and quality adjusted life years (QALY).

The variables will be collected at the beginning, on the day of treatment and at 1, 3, 6, 12 and 24 months. The enrollment period will be 24 months. The follow-up period will be 24 months.

The results of the study will allow a better understanding of the value of ozone therapy in the management of patients on the waiting list for herniated disc surgery. In addition, it will contribute to the development of a more patient-centered health system.

Conditions: Lumbar Herniated Disc
Keywords: Disc Herniation, Lumbar Herniated Disc, Ozone Therapy
Medical subject headings: Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03282695
Study group	Role	What they receive
Surgery		Patients on waiting list for surgery (by discectomy/microdiscectomy) who reject ozone infiltration during waiting time. These patients will receive standard pain treatment until the planned surgery.
Ozone		Patients on waiting list for surgery (by discectomy/microdiscectomy) who accept treatment by ozone infiltration during waiting time. These patients will be treated primarily by ozone therapy: Infiltration of intradiscal O3/O2 + foraminal infiltration of O3/O2 + corticoid + anesthetic. These patients will receive standard pain treatment until the planned surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

Direct Hospital Cost for patients included on waiting list for surgery due to disc herniation.
Euros
Measured: 24 months
Percentage of surgeries finally performed.
Percentage of surgeries performed after enrollment
Measured: 24 months
Change from Baseline in sciatic pain at 12 months
Visual Analogic Scale (VAS)
Measured: 12 months
Change from Baseline in sciatic pain at 24 months
Visual Analogic Scale (VAS)
Measured: 24 months

Secondary outcomes (13)

Change from Baseline in sciatic pain at 6 months
Visual Analogic Scale (VAS)
Measured: 6 months
Change from Baseline in lumbar pain at 6 months
Visual Analogic Scale (VAS)
Measured: 6 months
Change from Baseline in lumbar pain at 12 months
Visual Analogic Scale (VAS)
Measured: 12 months
Change from Baseline in lumbar pain at 24 months
Visual Analogic Scale (VAS)
Measured: 24 months
Number of hospital stay days
Number of hospital stay days
Measured: 24 months
Restriction of everyday activities
Spanish version of Roland-Morris questionnaire
Measured: 24 months
Quality of life by 12-Item Short Form Survey (SF-12)
SF-12 questionnaire
Measured: 24 months
Quality of life by the five-level version of the EuroQol five-dimensional (EQ-5D-5L) questionnaire
EQ-5D-5L questionnaire
Measured: 24 months
Loss of labour productivity
Off work days (if applicable)
Measured: 24 months
Time to resume normal activity
Days
Measured: 24 months
Direct sanitary and non-sanitary costs incurred out of hospital.
Euros
Measured: 24 months
Adverse effects
Number of serious adverse effects
Measured: 24 months
Time from inclusion on waiting list for surgery to completion of the procedure.
Days
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 201831 Mar 2026

First posted14 Sep 2017
Study start9 Mar 2018
Primary completion31 Dec 2023
Study completion31 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Lumbar Herniated DiscStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03282695
Sponsor's protocol ID: BCV-OZO-2016-01
Acronym: O3HDCIRUGIA
Status last verified: Sep 2026
First submitted: 12 Sep 2017
Last updated: 18 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Magalhaes FN, Dotta L, Sasse A, Teixera MJ, Fonoff ET. Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. 2012 Mar-Apr;15(2):E115-29.
PubMed 22430658
Sherman J, Cauthen J, Schoenberg D, Burns M, Reaven NL, Griffith SL. Economic impact of improving outcomes of lumbar discectomy. Spine J. 2010 Feb;10(2):108-16. doi: 10.1016/j.spinee.2009.08.453. Epub 2009 Oct 12.
PubMed 19819761
Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.
PubMed 18777603
Hansson E, Hansson T. The cost-utility of lumbar disc herniation surgery. Eur Spine J. 2007 Mar;16(3):329-37. doi: 10.1007/s00586-006-0131-y. Epub 2006 May 9.
PubMed 16683121
Luhmann D, Burkhardt-Hammer T, Borowski C, Raspe H. Minimally invasive surgical procedures for the treatment of lumbar disc herniation. GMS Health Technol Assess. 2005 Nov 15;1:Doc07.
PubMed 21289928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse
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All Lumbar Herniated Disc trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study
ClinicalTrials.gov ID: NCT03282695
Acronym / sponsor ID: O3HDCIRUGIA / BCV-OZO-2016-01
Conditions: Lumbar Herniated Disc
Keywords: Disc Herniation, Lumbar Herniated Disc, Ozone Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Bernardino Clavo, MD, PhDUniversity, hospital or other
Collaborators: Servicio Canario de Salud, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Instituto de Salud Carlos III, Colegio Oficial de Médicos de Las Palmas
Study start: 9 Mar 2018 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Mar 2026 (actual)
First posted: 14 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objective of this study is to estimate the cost-effectiveness of ozone therapy in patients on the waiting list for surgery due to disc herniation.

Detailed description

The variables will be collected at the beginning, on the day of treatment and at 1, 3, 6, 12 and 24 months. The enrollment period will be 24 months. The follow-up period will be 24 months.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Surgery	–	–Patients on waiting list for surgery (by discectomy/microdiscectomy) who reject ozone infiltration during waiting time. These patients will receive standard pain treatment until the planned surgery.
Ozone	–	–Patients on waiting list for surgery (by discectomy/microdiscectomy) who accept treatment by ozone infiltration during waiting time. These patients will be treated primarily by ozone therapy: Infiltration of intradiscal O3/O2 + foraminal infiltration of O3/O2 + corticoid + anesthetic. These patients will receive standard pain treatment until the planned surgery.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults with symptomatic lumbar herniated disc in whom conservative medical management has failed and: 1) in whom discectomy or microdiscectomy is indicated, 2) have been included in surgery waiting list by the Neurosurgery Department, 3) who meet criteria for potential benefit with ozone therapy and 4) who accept participating in the study by answering/filling in the specific study questionnaires (wether they accept or not the ozone therapy).

Key inclusion criteria (4 listed)

Diagnosed with a herniated and not calcified lumbar disc that presents as: not migrated protrusion and/or extrusion.
Evaluated and diagnosed by the Neurosurgery Department, having been chosen as an appropriate candidate for surgery consisting in discectomy or microdiscectomy, after meeting the following two criteria: 1) Sciatic pain, with a visual analogue scale (VAS) intensity ≥ 5, despite 6 weeks of conservative management, wether it exists lumbar pain or not and 2) Radiating pain that matches the MRI image showing one or more herniated discs (not to be considered those patients with two herniated discs and symptoms attributable to only one of the herniated discs).
Included in the surgery waiting list for a discectomy or microdiscectomy.
Patients who have signed and dated the study 's specific informed consent.

Key exclusion criteria (10 listed)

Patients who do not meet all the inclusion criteria.
Calcified and/or migrated herniated disc, and/or with a severe neurological deficits (cauda equine syndrome).
Herniated disc with surgical indication of laminectomy and/or arthrodesis (massive extrusion, sign of instability or other conditions under the neurosurgeon judgment).
Relevant clinical paresis that does not improve despite 6 weeks of full conservative management (patients with severe pain and mild paresis that only shows up in the physical exam are not to be excluded, but those who present with paresis as the main symptom -"clinically relevant"- must be).
Simultaneous symptomatic cervical or dorsal herniated discs.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Direct Hospital Cost for patients included on waiting list for surgery due to disc herniation.
Time frame: 24 months
Euros
Percentage of surgeries finally performed.
Time frame: 24 months
Percentage of surgeries performed after enrollment
Change from Baseline in sciatic pain at 12 months
Time frame: 12 months
Visual Analogic Scale (VAS)
Change from Baseline in sciatic pain at 24 months
Time frame: 24 months
Visual Analogic Scale (VAS)

13 secondary outcomes

Change from Baseline in sciatic pain at 6 months
Time frame: 6 months
Change from Baseline in lumbar pain at 6 months
Time frame: 6 months
Change from Baseline in lumbar pain at 12 months
Time frame: 12 months
Change from Baseline in lumbar pain at 24 months
Time frame: 24 months
Number of hospital stay days
Time frame: 24 months
Restriction of everyday activities
Time frame: 24 months
Quality of life by 12-Item Short Form Survey (SF-12)
Time frame: 24 months
Quality of life by the five-level version of the EuroQol five-dimensional (EQ-5D-5L) questionnaire
Time frame: 24 months
Loss of labour productivity
Time frame: 24 months
Time to resume normal activity
Time frame: 24 months
Direct sanitary and non-sanitary costs incurred out of hospital.
Time frame: 24 months
Adverse effects
Time frame: 24 months
Time from inclusion on waiting list for surgery to completion of the procedure.
Time frame: 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Background: PubMed 22430658Magalhaes FN, Dotta L, Sasse A, Teixera MJ, Fonoff ET. Ozone therapy as a treatment for low back pain secondary to herniated disc: a systematic review and meta-analysis of randomized controlled trials. Pain Physician. 2012 Mar-Apr;15(2):E115-29.
Background: PubMed 19819761Sherman J, Cauthen J, Schoenberg D, Burns M, Reaven NL, Griffith SL. Economic impact of improving outcomes of lumbar discectomy. Spine J. 2010 Feb;10(2):108-16. doi: 10.1016/j.spinee.2009.08.453. Epub 2009 Oct 12.
Background: PubMed 18777603Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.
Results publication: PubMed 16683121Hansson E, Hansson T. The cost-utility of lumbar disc herniation surgery. Eur Spine J. 2007 Mar;16(3):329-37. doi: 10.1007/s00586-006-0131-y. Epub 2006 May 9.
Results publication: PubMed 21289928Luhmann D, Burkhardt-Hammer T, Borowski C, Raspe H. Minimally invasive surgical procedures for the treatment of lumbar disc herniation. GMS Health Technol Assess. 2005 Nov 15;1:Doc07.
Report (June 2016) about Ozone therapy in disc herniation, from the Health Technology Assessment (HTA) Unit, Canary Health Service, SpainLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Lumbar Herniated Disc

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Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
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Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernardino Clavo, MD, PhD study chair

Dr. Negrín University Hospital, Las Palmas, Spain

Pedro G. Serrano-Aguilar, MD, PhD study director

Servicio de Evaluación. Servicio Canario de Salud. Spain

Renata Linertová, MD, PhD principal investigator

Fundación Canaria de Investigación Sanitaria (FUNCANIS)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Herniated Disc, run by Bernardino Clavo, MD, PhD at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Direct Hospital Cost for patients included on waiting list for surgery due to disc herniation. (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03282695, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.